LEAP Program for Irritable Bowel Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Oxford Biomedical Technologies, Inc.
Disqualifiers: Inflammatory bowel, Celiac, Cancer, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.
Will I have to stop taking my current medications?
The trial requires that you have been on a stable dose of your current medications for at least one month before joining. It does not specify that you need to stop taking them.
What data supports the effectiveness of the LEAP Program treatment for Irritable Bowel Syndrome?
Research shows that personalized dietary changes, like those in the LEAP Program, can significantly reduce IBS symptoms and improve quality of life. A study found that participants experienced a notable decrease in gastrointestinal symptoms and better overall well-being after following the program.
12345Is the LEAP Program safe for humans?
The available research does not provide specific safety data for the LEAP Program or its variations, but it suggests that dietary interventions, like elimination diets, are generally safe for most people with irritable bowel syndrome, except for those with certain eating disorders.
24567How is the LEAP Program treatment different from other treatments for IBS?
The LEAP Program is unique because it uses a personalized dietary approach based on the Leukocyte Activation Assay-MRT (a test that measures immune cell reactions to foods) to improve IBS symptoms, unlike standard elimination diets that broadly restrict certain foods without personalization.
24568Eligibility Criteria
This trial is for adults with moderate to severe IBS-D, diagnosed by Rome III or IV criteria. Participants must have been on a stable dose regimen for at least a month and be willing to follow the LEAP program for three months. They should not be pregnant, undergoing cancer treatment, have kidney failure, inflammatory bowel disease, celiac disease, or a BMI of 40+.Inclusion Criteria
Adult patients with an established diagnosis of IBS-D as determined by Rome III or IV Criteria
Must be on a stable dose regimen for at least 1 month prior to enrollment
Willing to follow the LEAP program for 3 months
+3 more
Exclusion Criteria
Pregnancy or planned pregnancy or lactation
You have had cancer in the past and are currently receiving treatment for it.
You have had kidney failure in the past.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants follow a tailored anti-inflammatory eating plan guided by a registered dietitian as part of the LEAP program
12 weeks
6 visits (in-person), 1 visit (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effectiveness of an anti-inflammatory eating plan tailored to individual needs using LAA-MRT results. It's guided by dietitians over three months and aims to manage symptoms of irritable bowel syndrome (IBS).
1Treatment groups
Experimental Treatment
Group I: ParticipantsExperimental Treatment1 Intervention
Individuals with Irritable Bowel Syndrome (IBS)
Lifestyle Eating and Performance (LEAP) Program is already approved in United States for the following indications:
🇺🇸 Approved in United States as LEAP Program for:
- Irritable Bowel Syndrome (IBS)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oxford Biomedical Technologies, Inc.Riviera Beach, FL
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Who Is Running the Clinical Trial?
Oxford Biomedical Technologies, Inc.Lead Sponsor
References
Consensus document on exclusion diets in irritable bowel syndrome (IBS). [2019]This paper summarizes the contents of a consensus document on exclusion diets in irritable bowel disease that was developed by a task force from SEPD, FEAD, SENPE, FESNAD, SEÑ, SEEN, SEGHNP, SEDCA and ADENYD. The complete document is available at the FEAD and in SENPE websites. Irritable bowel syndrome is a highly prevalent functional digestive disorder where, in addition to drugs, therapy includes diet and acquisition of healthy habits as basic elements for its control. In order to facilitate dietary counseling for these patients in daily practice, the present consensus document on the role of exclusion diets was developed. To this end, consensus opinions were collected from various experts in the national scientific societies aiming at establishing recommendations applicable to the health care of patients with irritable bowel syndrome.
Is Personalized Dietary Therapy Effective for Individuals With Irritable Bowel Syndrome? [2023]Introduction: Adverse reactions to foods and food additives have a critical role in clinical manifestations of irritable bowel syndrome (IBS). Personalized dietary modifications conducted under the supervision of a qualified health practitioner could considerably impact the clinical care and course of the condition. Objective: To investigate the clinical effectiveness of the Lifestyle Eating and Performance (LEAP) program based on the Leukocyte Activation Assay-MRT (LAA-MRT®) results in improving IBS symptoms and quality of life. Methods: The retrospective study included de-identified client records (n = 146) from private group practices seen by registered dietitians. The eligibility criteria were adults aged > 18 years old with an established diagnosis of IBS. Results: Participants were 46.7 ± 12.6 years old and had a BMI of 26.7 ± 6.1 kg/m2; the majority were female (87.0%) and followed-up by a registered dietitian for 10.1 ± 6.4 weeks. There was a significant reduction post-dietary intervention in overall Global Gastrointestinal Symptom Survey Scores (P < 0.001) and improvement in quality of life (P < 0.001). Conclusion: This study generates real-world evidence of an alternative treatment option for IBS using a personalized dietary approach. A more precise understanding of the effect of food intake reactions is vital for clinical improvements and enhancing health outcomes in IBS.
Follow-up of patients with functional bowel symptoms treated with a low FODMAP diet. [2022]To investigate patient-reported outcomes from, and adherence to, a low FODMAP diet among patients suffering from irritable bowel syndrome and inflammatory bowel disease.
Elimination Diets for Irritable Bowel Syndrome: Approaching the End of the Beginning. [2019]Dietary interventions have become a mainstay of treating patients with irritable bowel syndrome (IBS). Most of the available studies have focused on the benefits of elimination diets. While elimination diets can be highly effective, they should be avoided in patients with 2 emerging eating disorders: orthorexia nervosa and avoidant/restrictive food intake disorder. Similar to drug therapies, diet interventions are effective for only a subgroup of patients with IBS. They should be viewed as "a" therapy not "the" therapy for patients with IBS. It will be critical to develop strategies that utilize symptoms combined with biomarkers which parse patients with IBS by pathophysiology and in so doing, help providers to pick the right treatment for the right patient. At present, diet interventions are primarily focused on elimination of certain foods but there are an increasing number of supplementation studies which are lending support to the concept of "functional foods."
A 5Ad Dietary Protocol for Functional Bowel Disorders. [2020]Functional bowel disorders (FBDs) affect around 20% of the population worldwide and are associated with reduced quality of life and high healthcare costs. Dietary therapies are frequently implemented to assist with symptom relief in these individuals, however, there are concerns regarding their complexity, restrictiveness, nutritional adequacy, and effectiveness. Thus, to overcome these limitations, a novel approach, the 5Ad Dietary Protocol, was designed and tested for its efficacy in reducing the severity of a range of gastrointestinal symptoms in 22 subjects with FBDs. The protocol was evaluated in a repeated measures MANOVA design (baseline week and intervention week). Measures of stool consistency and frequency were subtyped based on the subject baseline status. Significant improvements were seen in all abdominal symptom measures (p < 0.01). The effect was independent of body mass index (BMI), age, gender, physical activity level, and whether or not the subjects were formally diagnosed with irritable bowel syndrome (IBS) prior to participation. Stool consistency and frequency also improved in the respective contrasting subtypes. The 5Ad Dietary Protocol proved to be a promising universal approach for varying forms and severities of FBDs. The present study paves the way for future research encompassing a longer study duration and the exploration of underlying physiological mechanisms.
The role of diet in the management of irritable bowel syndrome: a focus on FODMAPs. [2018]Irritable bowel syndrome is a common condition that negatively impacts quality of life and results in significant health care expenditures. The vast majority of IBS patients associate their symptoms with eating. Numerous randomized, controlled trials suggest that restriction of dietary FODMAPs improves overall symptoms, abdominal pain, bloating and quality of life in more than half of IBS sufferers. There is emerging data which suggests that other diets (gluten free, guided elimination diets) might also be of benefit to IBS patients. Areas covered: Comprehensive literature review on dietary therapies available for IBS to date and exploration into individualized dietary therapy development based on diagnostic testing. Expert commentary: FODMAP elimination identifies IBS patients who are sensitive to FODMAPs. Responders should undergo a structured reintroduction of foods containing FODMAPs to determine a patient's sensitivities. This information can then be used to create a personalized, less restrictive low FODMAP diet. Future research should focus on the identification of other effective diet therapies focusing on supplementation of functional foods in addition to elimination and the development of biomarker-based diet treatment plans which identify the right treatment for the right patient.
Effectiveness of Two Dietary Approaches on the Quality of Life and Gastrointestinal Symptoms of Individuals with Irritable Bowel Syndrome. [2020]To evaluate the effectiveness of a low FODMAP (fermentable oligosaccharides, monosaccharaides, disaccharides and polyols) diet in the relief of symptoms and an improvement of the quality of life in individuals with irritable bowel syndrome in comparison to a standard diet according to the British Dietetic Association's guidelines. A non-randomized clinical trial of adult patients with IBS was compared two diet interventions. An assessment of symptoms, quality of life, and nutritional status was performed before and after the four-week mark of intervention. Individuals from the Low FODMAP Diet (LFD) group were evaluated on a third moment, after the controlled reintroduction of FODMAPs. A total of 70 individuals were divided in two groups: Low FODMAP Diet (LFD; n = 47) and Standard Diet (SD; n = 23). 57 individuals completed the four-week intervention (LFD; n = 39; SD; n = 18). At the completion of four weeks, the symptoms improved in both groups (LFD: p < 0.01; DC: p < 0.05) but LFD led to a higher relief (p < 0.05), primarily with respect to abdominal pain and diarrhoea. Quality of life improved significantly in both groups, with no significant differences between SD vs LFD (p > 0.05). In the LFD group, the relief of symptoms observed at the four-week mark remained constant after reintroduction of FODMAPs. Both interventions seem to be effective for the relief of symptoms and quality of life, however LFD had higher effectiveness in the former. The results with LFD suggest it can be a preferred approach in individuals with diarrhoeal profile.
Irritable bowel syndrome and diet: where are we in 2018? [2022]The aim is to review the most recent advances in the evidence supporting the use of various dietary interventions for the management of irritable bowel syndrome (IBS).